Utilizing Motion Controlled Video Games and Botulinum Toxin A Treatment to Improve Motor Function, Activity and Participation in Persons With Spastic Cerebral Palsy - a Single-subject Design Study
Overview
- Phase
- Not Applicable
- Intervention
- IncobotulinumtoxinA
- Conditions
- Cerebral Palsy, Spastic
- Sponsor
- Sunnaas Rehabilitation Hospital
- Enrollment
- 25
- Primary Endpoint
- Goal Attainment Scale score after video games therapy
- Last Updated
- 6 years ago
Overview
Brief Summary
Cerebral palsy (CP) is a non-progressive condition of the central nervous system caused by immature brain damage before, during or after birth. Persons affected by CP experience disability of various types. In individuals with CP, one of the most frequent symptoms is limited hand function. Other issues that often occur are muscle weakness, spasticity and problems with balance.
Injection with Botulinum Toxin A (BoNT-A) is common treatment for spasticity in patients with injury in central nervous system, e.g. traumatic brain injury, stroke, spinal cord injuries and CP.The main goal of the project is to explore if motion controlled video game treatment alone or in combination with injection treatment with BoNT-A lead to improvement of hand function, activity and participation in adults with CP.
In the project, the investigators will evaluate if these two interventions improve balance in adults with CP.
Participants will be psychologically tested in the beginning and the end of the project to evaluate if interventions can have positive effect on psychological symptoms such as depression and anxiety, The project is multidisciplinary. It involves a doctor, a nurse, an occupational therapist, a physiotherapist and a psychologist. The team will in ordinary clinical practice examine participants. Individual goals will be set up in agreement with each participant. The goals will be measurable, achievable and time bound. By reviewing scope of agreed goals, the investigators will be able to summarize most frequent problems that CP patients experience in their daily life.
There will be 25 participants in the study and they will be followed for 9 months. During every visit the team will examine participants, perform relevant tests and obtain objective and subjective outcomes. It will be assessed to what degree the goals have been achieved.
The investigators also want to evaluate long term effects of the two intervention applied in the study. Therefore, the participants will be finally assessed 3 months after last intervention period.
Based on study results, implications for future treatment volume and organization of the rehabilitation for persons with spasticity will be discussed with the participating units, hospitals, municipalities and policy makers. Professionals included in this project are also clinicians and will have an important role in ensuring that the findings are included in clinical guidelines and educational activities.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults with CP (\>= 18 years)
- •Spastic CP with one upper extremity affected
- •Grasp function and ability to open and close the hand actively
- •"Spastic hand and arm" as a prevalent finding verified by clinical examination
- •Ability to walk
Exclusion Criteria
- •Musculoskeletal illnesses that affect limbs (e.g., arthrosis, rheumatoid arthritis and amputations).
- •BoNT-A treatment of upper limbs in the previous 6 months.
- •Orthopedic or neurosurgery procedures performed on the upper limbs in the last 12 months.
- •Wrist contracture that prevents patient to play video games
- •Severe cognitive deficits
- •Other neurological disorders and severe psychiatric illnesses
- •Active user of MCVG console at home
Arms & Interventions
Adults with hemiplegic spastic cerebral palsy
Adults (\> 18 years old) with hemiplegic spastic cerebral palsy, with reduced hand function and spasticity as prevalent finding under clinical examination. Also these patients can walk but have problems with balance. Participants' cognitive function does not limit them to perform video game training.
Intervention: IncobotulinumtoxinA
Adults with hemiplegic spastic cerebral palsy
Adults (\> 18 years old) with hemiplegic spastic cerebral palsy, with reduced hand function and spasticity as prevalent finding under clinical examination. Also these patients can walk but have problems with balance. Participants' cognitive function does not limit them to perform video game training.
Intervention: Video game
Outcomes
Primary Outcomes
Goal Attainment Scale score after video games therapy
Time Frame: 3 months after baseline
Goal Attainment Scale (GAS), where the participant defines specific problem, e.g., activity limitations and participation restrictions caused by upper limb function difficulties, and evaluates to what extent the goal is achieved after treatment and/or training. GAS have previously been utilized to quantify the treatment effects of BoNT-A. Each participant in collaboration with clinicians formulates specific short-term and long-term goals that correspond to the International Classification of Functioning, Disability and Health (ICF) Activity and Participation levels. Minimum scale value -2 (least favorable outcome), Maximum scale value +2 (most favorable outcome)
Goal Attainment Scale score 6 weeks after injection therapy with BoNT-A
Time Frame: 4.5 months after baseline
Goal Attainment Scale (GAS), where the participant defines specific problem, e.g., activity limitations and participation restrictions caused by upper limb function difficulties, and evaluates to what extent the goal is achieved after treatment and/or training. GAS have previously been utilized to quantify the treatment effects of BoNT-A. Each participant in collaboration with clinicians formulates specific short-term and long-term goals that correspond to the International Classification of Functioning, Disability and Health (ICF) Activity and Participation levels. Minimum scale value -2 (least favorable outcome), Maximum scale value +2 (most favorable outcome)
Goal Attainment Scale score 3 months after injection therapy with BoNT-A
Time Frame: 6 months after baseline
Goal Attainment Scale (GAS), where the participant defines specific problem, e.g., activity limitations and participation restrictions caused by upper limb function difficulties, and evaluates to what extent the goal is achieved after treatment and/or training. GAS have previously been utilized to quantify the treatment effects of BoNT-A. Each participant in collaboration with clinicians formulates specific short-term and long-term goals that correspond to the International Classification of Functioning, Disability and Health (ICF) Activity and Participation levels. Minimum scale value -2 (least favorable outcome), Maximum scale value +2 (most favorable outcome)
Goal Attainment Scale score at baseline
Time Frame: Baseline
Goal Attainment Scale (GAS), where the participant defines specific problem, e.g., activity limitations and participation restrictions caused by upper limb function difficulties, and evaluates to what extent the goal is achieved after treatment and/or training. GAS have previously been utilized to quantify the treatment effects of BoNT-A. Each participant in collaboration with clinicians formulates specific short-term and long-term goals that correspond to the International Classification of Functioning, Disability and Health (ICF) Activity and Participation levels. Minimum scale value -2 (least favorable outcome), Maximum scale value +2 (most favorable outcome)
Goal Attainment Scale score at the end of follow up period
Time Frame: 9 months after baseline
Goal Attainment Scale (GAS), where the participant defines specific problem, e.g., activity limitations and participation restrictions caused by upper limb function difficulties, and evaluates to what extent the goal is achieved after treatment and/or training. GAS have previously been utilized to quantify the treatment effects of BoNT-A. Each participant in collaboration with clinicians formulates specific short-term and long-term goals that correspond to the International Classification of Functioning, Disability and Health (ICF) Activity and Participation levels. Minimum scale value -2 (least favorable outcome), Maximum scale value +2 (most favorable outcome)
Secondary Outcomes
- Change from baseline Patient Specific Functional Scale score at project defined points of assesment(Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline)
- Gross Motor Function Classification System(Baseline)
- Manual Ability Classification System (MACS)(Baseline)
- Change from baseline Hand Grip Dynamometer score at project defined points of assesment(Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline)
- Zancolli Classification Hand Function(Baseline)
- House Functional Classification System(Baseline)
- Change from baseline Modified Ashworth Scales score at project defined points of assesment(Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline)
- Change from baseline Range of Motion score at project defined points of assesment(Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline)
- Change from baseline Numeric rating scale (0-10) of symptoms related to pain at 9 months(Baseline, 9 months after baseline)
- WAIS-IV Coding (Wechsler Adult Intelligence Scale )(Baseline)
- Change from baseline Hopkins Symptoms Checklist 25 score at 9 months(Baseline, 9 months after baseline)
- Change from baseline Action Research Arm Test (ARAT) score at project defined points of assesment(Baseline, 3 months after baseline, 4.5 months after baseline, 6 months after baseline, 9 months after baseline)
- Change from baseline Mini-Balance Evaluation Systems Test score at project defined points of assesment(Baseline, 3 months after baseline, 4.5 months after baseline, 6 months after baseline, 9 months after baseline)
- Change from baseline Fatigue Severity Scale (FSS) at 9 months(Baseline, 9 months after baseline)
- Change from baseline EQ-5D-5L (EuroQol 5 Dimensions 5 Level) Health related quality of life score at 9 months(Baseline, 9 months after baseline)